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Completed

NCT Number: NCT00932334

Culturally Sensitive Behavioral Interventions to Enhance Living Kidney Donation / Living Kidney Transplantation

Title: Culturally tailored behavioral interventions to enhance living kidney donation/living kidney transplantation Applicants: Johns Hopkins Medical Institutions, National Kidney Foundation of Maryland Principal Investigator: Neil R. Powe, MD, MPH, MBA Address: 2024 E. Monument Street, Suite 2-600, Baltimore, MD, 21205 Phone: 410-955-6953; Email: [email protected]; Fax: 410-955-0476 Rates of kidney donation have been largely stagnant for the past 10 years, resulting in large imbalances in numbers of persons on transplant waiting lists and the number of persons receiving kidney transplants. Slow improvement in donation and transplantation rates are exacerbated by ethnic/racial disparities in kidney transplants, in which minorities, particularly African Americans, are far less likely to receive deceased kidney transplants. Although living related kidney donation (LD) offers patients an opportunity to bypass many barriers contributing to disparities in kidney transplantation (e.g. waiting lists and immunological incompatibility issues), African Americans remain less likely to receive living related kidney transplants (LRT), further exacerbating disparities in transplant rates. Recent research demonstrates many ethnic minorities desire kidney transplantation, but rates of patient-physician and patient-family discussions regarding LD/LRT are suboptimal. Compared to Whites, African Americans have also been shown to have disproportionately greater rates of culture-specific concerns (such as mistrust in health care) that could impede them from seeking important medical therapies. It is unknown whether culturally tailored behavioral interventions to enhance patient/family decision-making regarding LD/LRT before the onset of end stage renal disease could improve rates of LD/LRT or could narrow racial disparities in the receipt of transplantation. The primary goal of this proposal is a) to use focus group methodology to develop culturally tailored educational materials for patients/families considering LD/LRT and b) to perform a randomized controlled trial to test the effectiveness of a culturally tailored social-worker led intervention (using established behavioral problem-solving therapeutic techniques) in enhancing rates of family communication, donor evaluations, and transplantation. The substantial experience of our consortium, including the National Kidney Foundation of Maryland and the Johns Hopkins Medical Institutions (Welch Center and the Medical Surgical Transplant Services in the School of Medicine), in the evaluation/ implementation of donor/recipient educational programs as well as the conduct of behavioral, epidemiologic and interventional studies related to donor/recipient health and psychology provides a strong foundation for the conduct of this study.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age 18 to 70 with stage IV or stage V (non-dialysis dependent) chronic kidney disease

Exclusion criteria

  • No evidence of cancer within 2 years prior to recruitment date
  • No evidence of stage IV congestive heart failure
  • No evidence of end-stage liver disease
  • No evidence of unstable coronary artery disease
  • No evidence of pulmonary hypertension
  • No evidence of severe peripheral vascular disease
  • No history of HIV
  • No chronic (debilitating) infections
  • No prior kidney transplant
  • No prior completion of transplant evaluation process
  • No prior dialysis treatment

Treatment and study plan

TALK PLUS

Behavioral

Participants receive and educational video and booklet about living kidney donation and meet with a social worker

TALK Standard

Behavioral

Participants receive and educational video and booklet about living kidney donation

Usual Care

Behavioral

Participants receive their usual care

Primary outcomes

  1. enhancing rates of family communication, donor evaluations, and transplantation

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Acronym: TALK

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 3, 2009
Registry last updated
Dec 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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